European Journal of Orthodontics, 2017, 1–12

doi:10.1093/ejo/cjx093

Systematic Review 1.55

1.5
Miniscrews failure rate in orthodontics:
systematic review and meta-analysis 1.60

Fahad Alharbi1, Mohammed Almuzian2 and David Bearn3

1.10 Department of Orthodontics, Prince Sattam Bin Abdulaziz University, Al Kharj, Saudi Arabia, 2Discipline of
1

1.65
Orthodontics, Faculty of Dentistry, University of Sydney, Sydney, Australia and 3Department of Orthodontics,
University of Dundee, Scotland, UK

Correspondence to: Mohammed Almuzian, Honorary Lecturer in Orthodontics, Discipline of Orthodontics, University of
1.15 Sydney, Sydney Dental Hospital, Sydney, New South Wales, Australia. E-mail: dr_muzian@hotmail.com
1.70

Summary
Background:  Miniscrews in orthodontics have been mainly used for anchorage without patient
1.20 compliance in orthodontic treatment. The literature has reported changing failure rates.
Objective:  The aim of this review was to provide a precise estimation of miniscrew failure rate and 1.75
the possible risk factors of the mechanically-retained miniscrews.
Search method: Electronic search in database was undertaken up to July 2017 through the
Cochrane Database of Systematic Reviews, MEDLINE, Scopus, and Ovid. Additional searching for
1.25
on-going and unpublished data, hand search of relevant journals and grey lietraure were also
1.80
undertaken, authors were contacted, and reference lists screened.
Eligibility criteria:  Randomised controlled trials (RCTs) and prospective cohort studies (PCSs),
published in English were obtained, which reported the failure rate of miniscrews, as orthodontic
1.30 anchorage, with less than 2 mm diameter.
Data collection and analysis:  Blind and induplicate study selection, data extraction, and risk of bias 1.85
assessment were undertaken in this research. Failure rates and relevant risk factors of miniscrews
with the corresponding 95 per cent confidence intervals (CIs) were calculated by using the random-
effects model. The heterogeneity across the studies was assessed using the I2 and Chi2 test. The
1.35
risk of bias was assessed using Cochrane risk of bias and Newcastle-Ottawa Scale. Subgroup and
sensitivity analyses were performed in order to test the robustness of the results in meta-analysis. 1.90
Results:  The 16 RCTs and 30 PCSs were included in this research. Five studies were not included
in the meta-analysis due to a lack of the statistical information needed to compute the effect
1.40 sizes. About 3250 miniscrews from 41 studies were pooled in a random-effect model. The overall
failure rate of miniscrews was 13.5 per cent (95% CI 11.5–15.9). Subgroup analysis showed that
miniscrews ‘diameter, length and design, patient age, and jaw of insertion had minimal effect on 1.95
rate of miniscrews failure while the type of the gingivae and smoking had statistically significant
effect.
1.45 Conclusion:  Miniscrews have an acceptably low failure rate. The findings should be interpreted with
caution due to high-level of heterogeneity and unbalanced groups in the included studies. High quality
randomized clinical trial with large sample sizes are required to support the findings of this review. 1.100

1.50

1.105

© The Author(s) 2017. Published by Oxford University Press on behalf of the European Orthodontic Society.
1
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 2 European Journal of Orthodontics, 2017

Introduction
Orthodontic skeletal anchorage devices are used by orthodontists
for a range of clinical applications. These include molar distalization,
molar protraction, intrusion of incisors, intrusion of molars, cross
2.5
bite or scissor bite correction, and anchorage reinforcement (1–7). It
was following Konami’s publication in 1997 that orthodontic skele-
tal anchorage devices, as we know them today, were popularized (8).
Orthodontic skeletal anchorage devices can broadly be divided
into two categories: osseo-integrated implants such as mid-palatal
2.10
implants (9) and on-plants (10), and mechanically retained devices
such as titanium mini-plates (11, 12), zygomatic wires, and minis-
crews (13, 14). The use of miniscrews has increased in orthodontics
treatment due to their ease of insertion and removal, reasonable
cost, biocompatibility, and capability to withstand orthodontic
2.15
forces (15, 16).
Publications regarding the mechanically retained miniscrews
increased dramatically from a few papers in the 1980s to above
5000 papers up until year 2017, indicating a huge interest in skel-
etal anchorage. Unfortunately, the vast majority of these papers are
2.20
case reports and biological science research and very few are clinical
trials published.
Miniscrews should ideally remain stationary when orthodontic
force is applied to be effective. The miniscrews stability has become
a problem because it does not ground on the osseointegration, but it
2.25
depends on mechanical locking of threads into the bony tissues and
they consequently could hold up the orthodontic loading. Several
factors contribute to the success of miniscrews which may be related
to the design, related to patient, or related to clinician factors. Age
is a factor related to patient with a higher failure rate reported in
2.30
adolescents as compared to adults as a result of the difference in the
buccal plate thickness (17). Poor oral hygiene and smoking are fur-
ther factors related to patient that reduce the survival rate of mini-
screws (18–20). Insertion site and type of the mucosa (keratinized
and non-keratinized mucosa) are further patient-related factors. In
2.35
general, miniscrews have been reported to have a good success rate
if inserted in the maxillary region and through keratinized gingivae
(17, 19, 21).
With regard to miniscrew design factors, it has previously been
concluded that miniscrews with a diameter between 1.1 and 1.6 mm
2.40
provide the best success rate (22). Similarly, miniscrews longer than
5–8  mm are more stable than shorter ones (19, 22). Clinician’s
­experience, sterilization and asepsis, loading protocol (23), implant
placement torque (24, 25), and insertion angle (26) have all been
implicated as clinician related factors that may significantly affect
2.45
the survival of miniscrews.
Recent reviews investigated the effectiveness of all types of skeletal
anchorage devices in anchorage provision in relation to conventional
methods (7, 27, 28). However, the findings of these reviews were
not specific to the most commonly used skeletal anchorage ­device,
2.50
that is mechanically retained miniscrews. As the d ­ etermination of
specific clinical parameters which influence the clinical success has
become critical, aim of this study was to conduct a systematic review
and meta-analysis of controlled and uncontrolled prospective clin-
ical trials to amend the actual knowledge about the miniscrews in
orthodontic clinical practice, specifically about their stability and 2.65
their associated risk factors.
Methods
This review received no specific grant from any funding agency in 2.70
the public, commercial, or not-for-profit sectors. This systematic
review was planned and reported accordingly with the preferred
reporting items for systematic review and meta-analysis (29) and
Cochrane Guidelines for Systematic Reviews (30). This review
was registered with International prospective register of systematic 2.75
reviews (PROSPERO, number CRD42017071441).
Criteria for included studies
The main research question was defined in PICO format (Table 2.80
1). The included studies in this systematic review were human
randmosied clinical trials (RCTs) and prospective cohort stud-
ies (PCSs) that were published in English till the date July 2017.
There was no restriction in the search strategy about the start-
ing date. Since the nature of this study was to aggregate the fail- 2.85
ure rates of miniscrews, therefore no comparators were needed.
Articles on miniscrews with a diameter greater than 2 mm, minis-
crews in vitro studies, animal studies, case reports and case series,
and review articles were excluded from this research. In cases of
unclear study design, the author was contacted twice for further 2.90
information. If there was no response from the author, the study
was excluded.
Search strategy 2.95
Controlled vocabulary and free text terms was used to allocate
published, ongoing, and unpublished studies. The vocabulary was
updated by following the initial search, if necessary, so as to iden-
tify all studies to be considered in this review. The following data-
2.100
bases were searched until 1st of July 2017 (Supplementary Table 1):
MEDLINE via PubMed, Cochrane Database of Systematic Reviews;
Scopus and Ovid. Other bibliographic databases were also searched
for ongoing and unpublished data including dissertation data, grey
literature in Europe, clinical trial registry, ISRCTN registry, disserta-
2.105
tion, and theses dissemination as well as Google Scholar until July
2017. A manual search was also carried out in relevant orthodontic
journals until July 2017. Reference lists of the included articles and
other relevant systematic reviews related to the topic were checked
for any additional relevant literature and also to include an add-
2.110
itional controlled vocabulary and free text terms if present. The
Cohen kappa statistic was used to assess the agreement between the
two review authors.

Table 1.  PICO format.

2.115
2.55 Population Participants having orthodontic treatment (in primary, secondary or tertiary care setting) and
requiring the insertion of miniscrews (less than 2 mm) with no restriction over the type of ortho-
dontic appliance, gender, or the presenting age of the patients
Intervention and comparators Any orthodontic treatment intervention involving the insertion of miniscrews
Outcome Primary outcome was the failure demonstrated by mobility, infection, inflammation or other fac- 2.120
2.60 tors leading to the premature loss of the miniscrews for the predefined study period
Secondary outcomes were the confounders and risk factors associated with miniscrews’ failure
 F. Alharbi et al.
Study selection and data extraction
Endnote reference manager software was used for removing dupli-
cate studies. Relevant articles were identified first after reading
their titles and abstracts. The full text of the potential articles was
3.5
assessed for eligibility by two reviewers (F.A.  and D.B.). With the
potential difficulties encountered while translating multiple arti-
cles into English, it was decided to only include articles present-
ing with a full text in English. However, this exclusion criterion
was applied following the primary search so as to avoid bias in the
3.10
search protocol.
Two reviewer (F.A., M.A.) blindly and independently extracted
study characteristics and outcomes using the customized data
extraction form developed by Papadopoulos and his colleagues
(7) with the potential disagreements solved by a third reviewer
3.15
(D.B.). The following information was included for each study:
year of publication, setting, study design, number of miniscrews
and their characteristics, success criteria, failure rate, and handling
of failure.
3.20
Assessment of risk bias in the included studies
RCTs were assessed for risk of bias using the Cochrane collaboration’s
tool (30). Each included study was assessed for the risk of bias in 1.
random sequence generation; 2. allocation concealment; 3. blind-
3.25
ing of outcome assessors; 4. incomplete outcome data; 5. selective
reporting; and 6. other sources of bias. Each RCT was assigned an
overall risk of bias, for example, low risk if all key domains have low
risk, high risk if more than one key domain has high risk and unclear
risk if more than one key domain has unclear risk.
3.30
PCSs were assessed for risk of bias using the Newcastle–Ottawa
Scale (NOS)(31). The NOS assesses the studies in the following three
domains: 1. selection; 2. comparability; and 3. outcome. In case of
disagreement between the two reviewers, a mutual decision through
discussion was made. Again, The Cohen kappa statistic was used to
3.35
assess the agreement between the two review authors with the poten-
tial disagreements solved by a third reviewer.
Data synthesis and meta-analysis
3.40
To calculate the failure rate of miniscrews, the original outcome
data were pooled in a random-effect model by using the statistical
software Comprehensive Meta-Analysis (Biostat Inc., Englewood,
New Jersey, USA) and a significance level of 5% was adopted for
all analyses. The pooled estimate was computed from studies that
3.45
reported similar intervention and outcomes. Failures of miniscrew
implants were expressed as event rates with their 95 per cent confi-
dence intervals (CI).
Taking in consideration the methodological and s­tatistical
heterogeneity, a random-effects model was used to assess all
3.50
pooled estimates (32). The heterogeneity across the studies
was assessed using the I2 and Chi2 test for heterogeneity (no
­heterogeneity = 0%, low = 25–49%, moderate = 50–74%, and high
75–100%) (33).
3.55
Other analysis
Subgroup and stratified analyses were pre-planned and pre-spec-
ified (a priori) to explore the effect of miniscrews’ length, diam-
eter, age group, jaw, the study design (RCT or cohort), and sample
3.60
size (100 TADs and more) pooled estimate. We also planned to
explore the effect of the miniscrew design, self-drilling miniscrews,
3
and non-self-drilling miniscrews that require pre-drilling pilot hole
before insertion, on the pooled estimate. Subgroup analyses were
planned to be used for a minimum of five studies.
3.65
Assessment of publication bias
Publication bias was assessed by visually inspecting the funnel plot
asymmetry. Moreover, two statistical methods were used to produce
significance tests in order to recognize publication bias: Begg/ 3.70
Mazumdar’s method (34) and Egger’s method (35).
Results
Study characteristics 3.75
There were 8636 hits from both electronic and manual searches.
After duplicate removal, studies were screened and in the result
7915 studies did not meet the inclusion criteria on the basis of title
and abstract (Figure 1). Another 152 of the qualifying studies were
3.80
excluded after their full texts were retrieved. This was because they
were laboratory studies, retrospective studies, systematic reviews,
or not relevant to the review topic. The final sample included 46
studies that met the primary inclusion criteria. The included studies
were 16 RCTs (36–51) and 30 PCSs (24, 52–80). Among the PCSs
3.85
there was 1 split mouth study. Five studies, two RCTs and three PCSs
were not included in the meta-analysis due to a lack of the statistical
information needed to compute the effect sizes (37, 47, 56, 58, 79).
However, they were included in the quality assessment of the stud-
ies. The authors were contacted twice via email when necessary to
3.90
obtain more information and, if no reply was received, the study
was excluded.
The main characteristics of the 46 included studies which col-
lectively included 3466 miniscrews are presented in Table  2. With
respect to the setting of study, 36 (78%) of the studies were based
3.95
purely on university settings, while the other 10 studies took place
in either private, hospital, mixed, or unknown settings. Generally,
the number of miniscrews used per participant ranged from 1 to 4
miniscrews and the average number per study was approximately
77 miniscrews.
3.100
There was considerable variation between the miniscrews’ manu-
facturers used in the included studies and in the dimensions of the
inserted miniscrews. The diameter of the inserted miniscrews ranged
from 1.2 to 2 mm and their length ranged from 5 to 15 mm. As pre-
sented, the recorded failure rate of miniscrews in the included studies
3.105
also ranged from zero to 40.8 per cent.
Risk of bias of included studies
The random sequence generation domain was assessed as adequate
3.110
in nine trials of the included RCTs while the remaining trials were
assessed as having high risk of bias or unclear risk (Table 3).
Allocation concealment domain was graded as having low risk of
bias in five trials only and the rest of the studies were assessed as
having unclear risk of bias or high risk of bias. The blinding of par-
3.115
ticipants and personnel was not possible in the included trials due to
the nature of orthodontic treatment. However, blinding of assessors
was possible and was carried out in 6 trials, in the remaining 10
studies either blinding was not performed or the reporting was not
adequate. There were no dropouts in the included trials. Therefore,
3.120
all included trials were assessed as having low risk of bias. Selective
bias domain was judged to have a low risk of bias in three trials. The
remaining studies were judged to have unclear risk of bias because
 4 European Journal of Orthodontics, 2017

Records idenfied through database

Idenficaon
Addional records idenfied through
searching other sources
(n = 8631) (n =5) 4.65
4.5

Records aer duplicates removed

(n =8113) 4.70
4.10
Screening

Records screened on the Records excluded

basis of tle and abstract (n = 7915) 4.75
4.15 (n = 8113)

Full-text arcles assessed

for eligibility Full-text arcles excluded, with
(n = 198) reasons 4.80
Eligibility

4.20 (n = 152)

Review Arcle = 16

Studies included in Unsupported opinion of expert = 9

qualitave synthesis
Not Relevant = 31 4.85
(n =46)
4.25
Retrospecve study = 40

Animal studies = 19
Included

Studies included in In vitro = 12

quantave synthesis 4.90
(meta-analysis) Other means of orthodonc
4.30
(n = 41) anchorage= 25

Figure 1.  Flow chart of the selection of studies.

4.35
no information was reported to allow judgment. The summary judg-
ment of risk of bias was assessed to be low in four trials only (36–39).
The remaining trials were judged to have overall high risk of bias
after all six domains’ assessment was performed (40–51).
With regard to the quality assessment of prospective cohort studies,
4.40
the vast majority of the these studies had mediumquality according to
the NOS (24, 52–76) (Table 4). Three studies were judged to have high
quality (77–79) and one study was judged to have low quality (80).
Overall miniscrews failure rate (primary outcomes)
4.45
Out of 46 studies, the primary outcome of this review, i.e. failure
rate of miniscrews, was reported in 41 studies. Data of 3250 mini-
screws were extracted and pooled in a random-effect model. The
pooled failure rate was 13.5 per cent (95% CI 11.5–15.9, P = 0.001,
I2 = 57.1%) (Figure 2). Data of 1391 miniscrews were extracted from
4.50
30 studies that included less than 100 miniscrews for each study that
were pooled in a random-effect model. The failure rate of 12.5 per
cent miniscrews (95% CI 9.7–16.1, P < 0.001, I2 = 60.23%) was
comparable to the summary points estimates of the effect size of
all the studies. Data from the 11 studies where each study included
4.55
more than 100 miniscrews were then analysed in a random-effect
model, the total number of miniscrews placed was 1893. The failure
rate of miniscrews was 14.3 per cent (95% CI 11.5–17.7, P = 0.027,
I2 = 71.5%). Similarly, in studies where more than 100 miniscrews
were placed, the rate did not differ considerably from the estimates
4.60
of the effect size of the main analysis.
4.95
Assessment of the miniscrew failure risk factors
(secondary outcomes)
Miniscrews diameter and length were reported more in studies than
any factor except for the location (maxilla or mandible). Diameter,
4.100
length, age, jaw of insertion, smoking status, and type of soft tissue
were investigated (Supplementary Table 2). Associated factors with
miniscrews failure were assessed in planned subgroup analysis when
possible.
Influence of study design on estimating the failure rate of mini-
4.105
screws was assessed (Supplementary Figure 1). Fourteen RCTs
that included 876 miniscrews were pooled in one random-effect
model as a part of the sensitivity analysis. Their failure rate was
13.3 per cent (95% CI 9.7–18, Q = 31.5 P < 0.001, I2 = 55.6%).
Interestingly, this was very close to the pooled failure rate (13.5%,
4.110
95% CI 11.1–16.4, Q = 76.54, P < 0.001, I2 = 67.34%) of 27 PCSs
that included 2374 miniscrews. Influence of length and design of
miniscrew on the estimation of failure rate of miniscrews was also
assessed (Supplementary Figures 2 and 3). The length of 8 mm was
used as a cut-off point to assess the effect of length of miniscrews
4.115
on the failure rate. The failure rate of the long miniscrews equal
or greater than 8 mm was (12.2%, 95% CI 6.7–21.4, Q = 15.2,
DF = 5, P < 0.001, I2 = 67.2%) and the failure rate for the short
miniscrews was 12.7% (95% CI 10.5–15.4, Q = 47.26, P < 0.001,
DF = 26, I2 = 44.9%).
4.120
Data from 11 studies that used non-self-drill miniscrews and
9 studies that used self-drill miniscrews were pooled. Miniscrews
 5.5

5.60
5.55
5.50
5.45
5.40
5.35
5.30
5.25
5.20
5.15
5.10
Table 2.  Characteristics of included studies.

Author Design Setting No. of No. of Type of miniscrews Dimensions Success criteria Failure rate Handling of
patients miniscrews (%) failure

Total Patient Diameter Length (mm)

F. Alharbi et al.

(per jaw) (mm)

Aboul-Ela et al. (40) RCT University 13 26 2 (2) AbsoAnchor (Dentos, Daegu, Korea) 1.3 8 Stability 7.7 Repositioned
Al-Sibaie and Hajeer (38) RCT University 30 56 2 (2) Dewimed®, Tuttlingen, Germany 1.6 7 Stability 5% Replaced
Alves et al. (52) PCS University 15 41 2–3 (2–3) (INP, São Paulo, Brazil) 1.4/2 6/8 Not recorded 14.6 Replaced
Apel et al. (53) PCS University 25 76 2–4 (2) Tomas-pin (Dentaurum, Ispringen, 1.6 8 Stability/Infection 10.5 Excluded
Germany)
Basha et al. (41) RCT University 14 14 2 (2) Stainless steel 1.3 8 Stability 28.6 Replaced
Bayat and Bauss (54) PCS Private 88 110 1–4 (1–2) LOMAS (Mondeal Medical Systems, 2 7/ 9 /11 Stability/Infection 18.2 Not recorded
Tuttlingen,Germany)
Bechtold et al. (42) RCT University 30 76 1–2 (1–2) Orlus 18107, Ortholution 1.8 7 Not recorded 13.4% Replaced
Berens et al. (61) PCS Private 85 239 1–3 (1–2) AbsoAnchor (Dentos, Daegu, Korea)/ 1.4/1.8/2 Not recorded Stability 15.1 Rescrewed/
Dual-Top (Jeil Medical, Seoul, Korea) excluded
Blaya et al. (66) PCS University/ 30 30 1 (1) Sin Implant System (São Paulo, Brazil) 1.2 10 Stability 0 Not recorded
private
Chaddad et al. (43) RCT Not 10 32 2–4 (2) C-Implant (Implantium,Seou, Korea)/Dual- 1.4-2 6-10 Stability/infec- 12.5 Not recorded
recorded Top (Jeil Medical, Seoul, Korea) tion/treatment
completion
Cheng et al. (65) PCS University 44 92 Not recorded Leibinger (Freiburg, Germany)/Mondeal 2 5-15 Stability/infec- 8.7 Not recorded
(Tuttlingen, Germany) tion/treatment
completion
Davoody et al. (77) PCS University 25 26 2 (2) NR 1.8-2 8-9 Not recorded 16% Replaced
El-Beialy et al. (64) PCS University 12 40 Not recorded AbsoAnchor (Dentos, Daegu, Korea) 1.2 8 Stability 17.5 Excluded
Falkensammer et al. (37) RCT University 26 Not Not recorded Dual Top G2 8x6mm, JeilMedical 1.6 8 Not recorded NR Not recorded
recorded Corporation, Seoul, Korea)
Garfinkle et al. (44) PCS University 13 82 4–8 (4) Osteomed (Addison, Tex) 1.6 6 Stability/treatment 19.5 Not recorded
completion
Gelgör et al. (63) PCS University 25 25 1 (1) IMF Stryker (Leibinger, Germany) 1.8 14 Stability 0 Not recorded
Gupta et al. (55) PCS University 20 40 2(2) Custome made (Denticon, Mumbai) 1.4 8 Stability 22.5 Not recorded
Hedayati et al. (62) PCS University 10 27 3 (1–2) Orthognathic screws 2 9/11 Stability 18.5 Repositioned
Herman et al. (71) PCS Not 16 49 1-2 (1–2) Ortho Implant (IMTEC, Ardmore, Okla), 1.8 6/8/10 Stability 40.8 New/
recorded Sendax MDI Excluded
Iwai et al. (70) PCS University 80 142 2 (2) Orthodontic anchor screws (ISA, BIODENT, 1.6 8 Stability/mobility/ 8.5%-5.6% Not recorded
Tokyo, Japan) contacted root
Khanna et al. (56) PCS University 25 100 Not recorded S.K. Surgical Pvt. Ltd. 1.3 9 Not recorded Not recorded Not recorded
Kim et al. (57) PCS University 25 50 2 (2) C-Implant (Implantium, Seoul, Korea) 1.8 8.5 Stability 4 Replaced
Lehnen et al. (45) RCT Not 25 60 2 (2) Tomas-pin (Dentaurum, Ispringen, 1.6 8 Not recorded 11.7 Excluded
recorded Germany)
Liu et al. (46) RCT Not 34 68 2 (2) (Cibei, Ningbo, China) 1.2 8 Stability 11.8 Replaced
recorded
Luzi et al. (69) PCS University 98 140 Not recorded Aarhus Mini-Implants (Medicon, Germany) 1.5/2 9.6/11.6 Stability/treatment 15.7 Excluded
completion
5

5.95
5.90
5.85
5.80
5.75
5.70
5.65

5.120
5.115
5.110
5.105
5.100
 6.5

6.60
6.55
6.50
6.45
6.40
6.35
6.30
6.25
6.20
6.15
6.10
6

Table 2.  (Continued )

Author Design Setting No. of No. of Type of miniscrews Dimensions Success criteria Failure rate Handling of
patients miniscrews (%) failure

Total Patient Diameter Length (mm)

(per jaw) (mm)

Ma et al. (47) RCT University 60 4 (2) AbsoAnchor (Dentos, Daegu, Korea)/Dual- 1.8 5/ 6 Not recorded Not recorded Not recorded
Top (Jeil Medical, Seoul, Korea)
Miyazawa et al. (68) PCS University 18 44 Not recorded (Jeil Medical, Seoul, Korea) 1.6 8 Treatment 9.1 Not recorded
completion
Motoyoshi et al. (24) PCS University 41 124 1–4 (1–2) ISA orthodontic implants (BIODENT, 1.6 8 Stability 14.5 Not recorded
Tokyo, Japan)
Motoyoshi et al. (76) PCS University 57 169 1–4 (1–2) (BIODENT, Tokyo, Japan) 1.6 8 Stability/treatment 14.8 Not recorded
completion
Motoyoshi et al. (74) PCS University 32 87 Not recorded ISA orthodontic implants (BIODENT, 1.6 8 Stability/treatment 12.6 Not recorded
Tokyo, Japan) completion
Motoyoshi et al. (67) PCS University 52 148 Not recorded ISA orthodontic implants (BIODENT, 1.6 8 Stability 9.5 Excluded
Tokyo, Japan)

Motoyoshi et al. (75) PCS University 65 209 1–4 (1–2) ISA orthodontic implants (BIODENT, 1.6 8 Stability/treatment 11.5 Not recorded
Tokyo, Japan) completion
Polat-Ozsoy et al. (80) PCS University 11 22 2 (2) AbsoAnchor (Dentos, Daegu, Korea) 1.2 6 Stability/Infection 13.6 Replaced
Sandler et al. (36) RCT Hospital 71 44 2(2) American Orthodontics 1.6 8 Not recorded 2.8% Not recorded
Sar et al. (58) PCS University 28 28 2(2) Stryker, Leibinger, Germany 2 8 Not recorded Not recorded Not recorded
Sarul et al. (73) Split University 27 54 2 (2) OrthoEasy Pin Not 6/ 8 Mobility/stability 26% Not recorded
mouth (Forestadent, Phorzheim, Germany) recorded
PCS
Sharma et al. (39) RCT University 46 30 2(2) Denticon 1.2 8 Stability 3% Replaced
Son et al. (78) PCS University 70 140 2 (2) (ISA self-drill type anchor screw; Biodent, 1.6 8 Mobility/stability 4% Not recorded
Tokyo, Japan)
Thiruvenkatachari et al. PCS University 10 18 1–2 (1–2) Titanium microimplant 1.3 8 Stability 0 Not recorded
(72)
Türköz et al. (48) RCT University 62 112 1–2 (1–2) AbsoAnchor (Dentos, Daegu, Korea) 1.4 7 Stability 22.3 Not recorded
Yoo et al. (60) PCS University 132 227 Not recorded Biomaterial Korea 1.5 7 Stability/problems 19.5 Not recorded
in loading
Upadhyay et al. (49) RCT University 33 72 4 (2) Modified Ti fixation screws 1.3 8 Stability 6.9 Replaced
Upadhyay et al. (51) PCS University 30 30 2 (2) Modified Ti fixation screws 1.3 8 Stability 10 Replaced
Upadhyay et al. (59) PCS University 40 46 2 (2) Ti mini-implants 1.3 8 Not recorded 4.3 Replaced
Upadhyay et al. (79) PCS University 34 28 2 (2) Ti mini-implants 1.3 8 Not recorded Not recorded Not recorded
Wiechmann et al. (50) RCT Not 49 133 AbsoAnchor (Dentos, Daegu, Korea)/dual- 1.2/1.6 5/10 Stability/treatment 23.3 Not recorded
recorded Top (Jeil Medical, Seoul, Korea) completion/
infection

PCS, prospective cohort study; RCT, randomised clinical trial.

European Journal of Orthodontics, 2017

6.95
6.90
6.85
6.80
6.75
6.70
6.65

6.120
6.115
6.110
6.105
6.100
 F. Alharbi et al. 7

Table 3.  Risk of bias assessment of the included RCTs.

Random Blinding of
sequence Allocation outcome Incomplete Selective Overall risk
Author Study type generation concealment assessors outcome data reporting Other bias of bias 7.65
7.5
Aboul-Ela et al. (40) RCT Yes Unclear No Yes Unclear No High risk
Al-Sibaie and Hajeer RCT Yes Yes Yes Yes Yes Yes Low risk
(38)
Basha et al. (41) CCT No No No Yes Unclear Yes High risk 7.70
Bechtold et al. (42) RCT Yes Unclear No Yes Unclear No High risk
7.10
Chaddad et al. (43) CCT No No No Yes Unclear No High risk
Falkensammer et al. RCT Yes Yes Yes Yes Unclear Yes Low risk
(37)
Garfinkle et al. (44) RCT Unclear Unclear No Yes Unclear No High risk
Lehnen et al. (45) RCT Unclear Unclear Yes Yes Unclear Yes High risk 7.75
7.15 Liu et al. (46) RCT Yes Unclear No Yes Unclear No High risk
Ma et al. (47) RCT Yes Unclear Yes Yes Unclear No High risk
Sandler et al. (36) RCT Yes Yes Yes Yes Yes No Low risk
Sharma et al. (39) RCT Yes Yes Yes Yes Yes Yes Low risk
Türköz et al. (48) RCT Unclear Unclear No Yes Unclear No High risk 7.80
Upadhyay et al. (51) CCT No No No Yes Unclear Yes High risk
7.20
Upadhyay et al. (49) RCT Yes Yes Unclear Yes Unclear Yes Unclear
Wiechmann et al. (50) RCT Unclear Unclear No Yes Unclear Yes High risk

CCT, controlled clinical trial; RCT, randomized clinical trial.

7.25 failure rate was 14.9 per cent (95% CI 10.4–20.8, Q = 20.7, DF = 8,
P < 0.001, I2 = 88.9%) in the non-self-drill miniscrews group which
was not significantly different from the estimate effect in the self-
drill miniscrews (14.2%, 95% CI 5.6–31.8, Q = 51.57, P < 0.001,
I2 = 71.41%).
7.30
Only one study (54) evaluated the association between smok-
ing and miniscrews failure rate and it included 110 miniscrews.
Seventy-three miniscrews were placed in non-smokers, 18 mini-
screws for light smokers (≤10 cigarettes/day), and the rest for
heavy smokers (≥10 cigarettes/day). The failure rates were 9.5,
7.35
11, and 57.8 per cent respectively. Moreover, one trial (43)
reported on the influence of type of gingivae at insertion site.
Thirty-two miniscrews were included in the study, those were
placed in keratinized tissue (11 miniscrews) showed no failure, 4
out of 21 miniscrews (19%) that were placed in non-keratinized
7.40
tissue failed.
Publication bias analysis
Supplementary Figure  4 shows a funnel plot of studies where
7.45 the effect sizes were plotted against standard error. The verti-
cal line represents the estimate of weighted mean effect size. As
one would expect, studies with a smaller sample size and large
sampling error would scatter toward the bottom of the funnel
plot. If publication bias is not present, the data points would nor-
7.50 mally expect to be distributed symmetrically around the mean
effect size estimate. In this current meta-analysis, the shape of
the inverted funnel plot was asymmetrical between the right and
the left sides of the plot, which means that there was absence of
smaller sized studies towards the right side of the plot. Therefore,
7.55 a considerable publication bias due to a failure of including
studies with small effect sizes seems likely in this meta-analy-
sis. Furthermore, both Begg’s test (Kendall’s tua  =  −0.34535,
P = 0.00131) and Egger’s test (−1.789, 95% CI −2.70 to −0.874,
P = 0.00017) s­ uggested that publication bias may be present in this
7.60 meta-analysis.
7.85
Discussion
This systematic review included 16 randomised clinical trials and
30 prospective cohort studies, in which the miniscrews were used to
reinforce orthodontic anchorage. The majority of the included trials 7.90
were judged as having a high risk of bias. In most of these trials, ran-
domization and allocation concealment procedures were either inad-
equate or reported incompletely. The quality of most of prospective
cohort studies was medium. This can be attributed to the fact that
most of included cohort studies did not include a comparison group, 7.95
thus, they had a lower score in the NOS.
The meta-analysis estimated the miniscrews failure rate to be
13.5 per cent (95% CI 11.5–15.9). Sensitivity analysis, after exclud-
ing small studies, showed almost similar pooled failure rate of mini-
screws (14.3%) to the overall estimate effect indicating adequate 7.100
robustness of the results. This finding differed slightly from the
failure rate that was previously reported by Papageorgiou et al. (7)
who reported a failure rate of 13.5 per cent (95% CI 11.5–15.8).
The minor difference between the two estimates might have resulted
from including additional studies in our meta-analysis (38, 42, 55, 7.105
59, 60, 77, 78). Secondly, we excluded retrospective studies, studies
with unclear design or studies in language other than English that
had been included in the previous meta-analysis (80).
Associated factors with miniscrews failure were assessed in sub-
group analyses. It appeared from the findings of this meta-analysis 7.110
that miniscrews with diameter smaller than 1.3 mm had lower fail-
ure rate (10.7%, 95% CI 7.6–15) when compared with miniscrews
with diameter of 1.4–1.6  mm (13.6%, 95% CI 10.3–17.1) and
diameter of 1.7–2  mm (14.4%, 95% CI 8.8–23.5). However, the
number of included miniscrews with small diameter was 450 while 7.115
the included miniscrews with medium diameter were 1586 and the
ones with large diameter were 391. This variation in sample size
between the included miniscrews and the heterogeneity may have
influenced the conclusiveness of the findings. Papageorgiou et al. (7)
found comparable failure rates for miniscrews of small and large 7.120
diameter: 10.9 per cent (95% CI 7.7–15.3) and 14.3 per cent (95%
 8.5

8.60
8.55
8.50
8.45
8.40
8.35
8.30
8.25
8.20
8.15
8.10
8

Table 4.  Risk of bias assessment of included cohort studies using Newcastle–Ottawa Scale (NOS).

Selection Comparability Outcome

Demonstration that out-

come of interest was not
Representativeness Selection of non- Ascertainment of present at the start of Comparability of Assessment Was follow-up Adequacy NOS Overall
Study of exposed cohort exposed cohort exposure the study the cohorts of outcome long enough? of follow-up score assessment

Alves et al. (52) 1 0 1 1 0 1 1 1 6 Medium

Apel et al. (53)
Bayat and Bauss (54)
Berens et al. (61)
Blaya et al. (66)
Cheng et al. (65)
Davoody et al. (77)
El-Beialy et al. (64)
Gelgör et al. (63)
Gupta et al. (55)
Hedayati et al. (62)
Herman et al. (71)
Iwai et al. (70)
Khanna et al. (56)
Kim et al. (57)
Luzi et al. (69)
Miyazawa et al. (68)
Motoyoshi et al. (67)
Motoyoshi et al. (76)
Motoyoshi et al. (74)
Motoyoshi et al. (75)
Motoyoshi et al. (24)
Polat-Ozsoy et al. (80)
Sar et al. (58)
Sarul et al. (73)
Son et al. (78)
Thiruvenkatachari et al. (72)
Yoo et al. (60)
Upadhyay et al. (59)
Upadhyay et al. (79)
1 0
0 1
1 0
1 0
1 0
1 1
0 0
1 0
1 1
1 0
1 0
1 1
1 0
1 0
1 0
1 0
1 0
1 0
1 0
1 0
1 0
1 0
1 0
1 1
1 0
1 0
0 0
1 0
1 0
1 1 0 1 1 1 6 Medium
1 1 1 0 0 1 5 Medium
1 1 0 1 1 1 6 Medium
1 1 0 1 1 1 6 Medium
1 1 0 0 1 1 5 Medium
1 1 1 0 1 1 7 High
1 1 0 1 1 1 5 Medium
1 1 0 1 1 1 6 Medium
1 1 0 0 1 1 6 Medium
1 1 0 1 1 1 6 Medium
1 1 0 1 1 1 6 Medium
1 1 0 0 1 1 6 Medium
1 1 0 0 1 0 4 Medium
1 1 0 1 1 1 6 Medium
1 1 0 1 1 1 6 Medium
1 1 0 1 1 1 6 Medium
1 1 0 0 1 1 5 Medium
1 1 0 0 1 1 5 Medium
1 1 0 0 1 1 5 Medium
1 1 0 1 1 1 6 Medium
1 1 0 0 1 1 5 Medium
1 0 0 0 0 1 3 Low
1 1 0 0 1 1 6 Medium
1 1 0 0 1 1 6 Medium
1 1 1 1 1 1 7 High
1 1 0 1 1 1 6 Medium
1 1 1 1 1 1 6 Medium
1 1 0 1 1 1 6 Medium
1 1 1 1 1 1 7 High
European Journal of Orthodontics, 2017

8.95
8.90
8.85
8.80
8.75
8.70
8.65

8.120
8.115
8.110
8.105
8.100
 F. Alharbi et al.
9.5
9.10
9.15
9.20
9.25
9.30
9.35
9.40
9.45
Figure 2.  Forest plot of overall miniscrews failure rate (random-effect model).
CI 7.4–25.8), respectively. However, they found that miniscrews
with medium diameter had failure rate of 12.7 per cent (95% CI
9.50 8.1–19.3). Lim and his team conducted two retrospective studies and
found that the miniscrew diameter had no significant effect on the
success of miniscrew (81,82). Furthermore, the difference between
large and medium size diameter was minimum, approximately 0.8
per cent. This was proven in previous study that diameter greater
9.55 than 1.6 mm seems to confer no significant benefit as wide minis-
crews are associated with higher risk of root contact than narrow
miniscrews (22).
The miniscrews in this meta-analysis were subdivided into
short (≤8 mm) and long (>8 mm) group. Most of the studies used
9.60 short miniscrews (Supplementary Table 2). The failure rate of
short miniscrews was 12.7 per cent (95% CI 10.5–15.4) which
is slightly larger than the failure rate of long miniscrews (8.3%,
9
9.65
9.70
9.75
9.80
9.85
9.90
9.95
9.100
9.105
95% CI 3.1–20.2). It is at the discretion of the clinician to consider
this difference clinically significant or not, but theoretically, longer 9.110
miniscrews should have a lower failure rate as they offer better
mechanical retention in the bone than shorter miniscrew. Lim
et al. (82) found higher failure rate (25%) with miniscrews of 6
mm or less, whereas miniscrews longer than 6mm had lower failure
rate (<12%). This could be due to the significant heterogeneities 9.115
in the subgroup analysis, thus, this finding is not conclusive and it
should be interpreted with caution. Furthermore, in this review an
arbitrary cut-off point of 8 mm was adopted to assess the effect of
length of miniscrew on the failure rate; hence, the possibilities of
the overlap of the findings on either side of the cut-off point is high, 9.120
i.e. those miniscrews with 7.9 mm or less will be included in the
short group. It is acknowledged that this cut-off point carries weak
specificity on the pooled estimate.
 10
The design of the miniscrews was compared in a small number
of included studies and did not have any effect on the failure rate
according to our findings. The failure rate of self-drilling minis-
crews was 14.2 per cent (95% CI 5.6–31.8) and for the non-self-
10.5 drilling it was 14.9 per cent (95% CI 10.4–20.8). Similar finding
was reported by Papageorgiou et  al. (7) for the non-self-drilling
miniscrews (17.7%, 95% CI 5.1–44.9) but was significantly lower
in self-drilling group (7.7%, 95% CI 4.8–12.0). This discrepancy
might be due to the fact that we extracted the data of miniscrews
10.10 design from nine studies compared to three studies in Papageorgiou
and team review (7), this might have influenced the estimation of the
failure rate. Moreover, this could be due to the significant heteroge-
neities in the subgroup analysis, thus, this finding is not conclusive
and it should be interpreted with caution. Interestingly, Chen et al.
10.15 (17) in their retrospective study found that self-drilling miniscrews
had higher failure rate (33%) when compared with non-self-drilling
(10%) (83), though this difference was not significant.
Age is a patient-related factor with a higher failure rate in adoles-
cents than adults potentially as a result of the difference in the buccal
10.20 plate thickness (17). In this review, most studies recruited a mix of
young (≤18 years) and adult patients (>18 years). The failure rate of
miniscrews placed in young patents was 8.6 per cent (95% CI 4.7–
15.1) which is lower than the failure rate reported by Papageorgiou
et al. (7) who found that the failure rate in patients younger than 20
10.25 years was 12.6 (95% CI 6.4–23.3). The difference between the two
estimates was not significant and could be the result of the variation
in the included studies between the two meta-analyses. Similarly, the
failure rate of miniscrews placed in adults according to our ana-
lysis was 11.2 per cent (95% CI 6.6–18.7) compared to 15.5 per
10.30 cent (95% CI 11.2–21.0) in Papageorgiou and team review (7). In
contrary, retrospective studies (82, 84) showed that older patients
had higher failure rate probably due to smoking and compromised
periodontium. Moreover, these findings may simply be a function
of sample size, as there were more miniscrews inserted in younger
10.35 participants than adults.
In our analysis, the failure rate of miniscrews placed in the max-
illa was 11.0 per cent (95% CI 8.8–13.7) while the failure rate of
those placed in the mandible was 16.5 per cent (95% CI 11.6–22.7).
The higher failure rate in the mandible may be caused by the greater
10.40 bone density, the limited amount of cortical bone around the mini-
screws, and the narrow vestibule compared with the maxilla (84).
However, it is important to consider the significant degree of hetero-
geneities in the subgroup analysis during interpretation of the data.
Data regarding to the effect of smoking on the failure rate of mini-
10.45 screws was extracted from only one study (54) in our review and it
appears that smoking has a negative effect on miniscrew stability
although there is very limited data to support this fact.
The type of mucosa insertion and its relationship to the miniscres
failure rate was investigated in only one study (43). Chaddad and
10.50 colleagues found that 11 miniscrews placed in the keratinized tissue
had no failures. On the other hand, 1 out of 5 miniscrews would
fail when it is inserted through the mobile non-keratinised gingivae.
Limitations of the study
10.55
The overal failure rate of the miniscrews should be read with cau-
tion due to the significant heterogeneity (Q = 86.34, P > 0.001, I2
= 57.1%) between the studies. This is to be expected because the
included studies had different designs, sample sizes and methods.
Inspection of the funnel plot and statistically significant Egger’s test
10.60
and Begg’s test suggested that publication bias is likely to be present.
This bias is expected because the included studies in this meta-analy-
sis and not all of the included trials were meta-analysed because the
European Journal of Orthodontics, 2017
authors did not report data on failure rate of miniscrew. Additionally,
the asymmetry in the funnel plot may have raised because of true meth-
odological and statistical heterogeneity. It is worth noting that the fun-
nel plot is able to indicate the presence of the publication bias but it 10.65
cannot explain the reasons for the asymmetry (83, 85).
Conclusion
10.70
• The included studies in this meta-analysis were a mix of clinical
trials that mostly had a high risk of bias and prospective cohort
studies with mostly moderate quality.
• The failure rate of miniscrews was modest (13.5%, 95% CI
11.5–15.9) which suggests that miniscrews are clinically reliable.
10.75
• Subgroup analysis showed that with the possible exception of
smoking and type of mucosal insertion, the assessed risk factors
had very minor effects on miniscrew survival. However, the sub-
goup analysis should be interpted with caution due to high-level
hetrogniety and unbalanced and small groups.
10.80
• High quality RCTs with large sample sizes are required to sup-
port the findings of this review.
Supplementary material 10.85
Supplementary material is available at European Journal of
Orthodontics online.
Conflict of interest 10.90
None to declare.
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